Kornimate/medical-research-clean huggingface dataset:
study of pioglitazone in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: primary objective: efficacy of pioglitazone (45 mg/day) as add-on therapy to standard therapy with riluzole in patients with als compared to placebo in terms of survival (mortality defined exclusively as death). this is a prospective, multicentre, randomised, stratified, parallel-group, double-blind trial comparing placebo with 45 mg pioglitazone as add-on therapy to 100 mg riluzole in als in 220 enrolled patients. for entry, the el escorial criteria for diagnosis will be used. the duration of treatment will be 18 months. the primary endpoint will be subjected to a confirmatory analyses. secondary variables will be incidence of tracheotomy or non-invasive ventilation, als functional rating scale, quality of life and safety variables.


Eligibility criteria:
inclusion criteria: * possible, probable (clinically or laboratory) or definite als according to the revised version of the el escorial world federation of neurology criteria * disease duration more than 6 months and less than 3 years * best-sitting fvc between 50% and 95% of predicted normal * continuously treated with 100 mg riluzole daily, for at least one month * onset of progression weakness within 36 months prior to study * women of childbearing age be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test * capable of thoroughly understanding all information given and giving full informed consent according to gcp exclusion criteria: * previous participation in another clinical study within the preceding three months * tracheotomy or assisted ventilation of any type during the preceding three months * gastrostomy * any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of als * presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment * confirmed hepatic insufficiency or abnormal liver function (asat and/or alat more than 1.5 upper limit of normal) * renal insufficiency (serum creatinine more than 2.26 mg/dl) * evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms * known hypersensitivity to any component of the study drugs * likely to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of an emergency * other antidiabetics * heart failure or heart failure in the patients history (nyha i to iv) * history of macular oedema * treatment with thiazolidinediones within 3 months prior to screening * known or suspected history of alcohol and/or drug abuse * treatment with gemfibrozil within 3 months prior to screening

Keywords: amyotrophic lateral sclerosis survival time als functioning rating scale quality of life non-invasive ventilation clinical tolerability survival
prospective evaluations of infectious complication in lung transplant recipients

Conditions: Disorder Related to Lung Transplantation; Bronchiolitis Obliterans

Summary: the primary aim of this study is to determine prospectively the viral and c. pneumoniae infection prevalence and outcomes of infections in lung transplant recipients. the study will also determine the correlation of c. pneumoniae infection with the development of obliterans in lung transplant recipients.

this is a prospective cohort study of lung transplant recipients and those who will undergo lung transplantation. patients will be identified by the pulmonologist performing the bronchoscopy. the patient's sera (obtained from a one time blood draw of 10 milliliters - two tablespoons) and cell pellet of bal will be frozen at -70º c. once the active or non- ob status is determined by the pathologist, stored bal fluid (cell pellet) will be analyzed. c.pneumoniae serum titers will also be measured and compared with stored pre-transplant sera. left over cell pellet of the bal fluid will be used to measure the presence of c. pneumoniae by pcr method. additionally pcr will be performed for other viruses (cmv, ebv, hhv6 \& 7, human metapneumo virus and human rhino virus). in addition, during the bronchoscopy procedure as part of the patient's standard of care, a biopsy is obtained. this is done during the bronchoscopy procedure. the tissue is then sent to the pathology lab. we will collect residual (excess) tissue samples to perform research related testing. this testing will determine if we can predict other types of infections and early onset of rejection. these determinations will assist clinicians in administering appropriate dosage levels of antibiotics required to prevent or treat infections and help stop the rejection process. the subject will be asked a few questions about pulmonary symptoms that will not take more than five minutes by one of the investigators or study coordinator. the subject's medical record will be reviewed for demographic information (age, sex, and race), lab results (standard to post transplant care), medication information, as well as any testing/procedures during the transplant follow-up period. this information and results of the tests/procedures will become part of the research record.

Eligibility criteria:
inclusion criteria: * patients who have undergone lung transplantation or will undergo a lung transplant at the university of pittsburgh medical center and are alive following transplant period will be eligible for the study. exclusion criteria: * subjects not willing to participate in the research study.

Keywords: lung transplant
evaluation of the safety and efficacy of oshadi d and oshadi r for cancer treatment

Conditions: Tumor; Cancer; Metastasis

Summary: the study will be non randomized, open label, dose rising study in cancer patients. cancer treatment is consisting of 2 different drugs: oshadi d and oshadi r that will be administered orally. the study will include two sessions: * a single dose period to evaluate acute toxicity of each drug * consecutive multiple increment dose escalation period of both drugs to determine the long-term safety, and the anticancer activity.


Eligibility criteria:
inclusion criteria: * histologically/ cytological proven solid tumor that is metastatic. * age \> 21 years old. * ecog performance status \< 2. * documented progressive metastatic disease according to recist criteria. * at least one lesion not within prior radiation field that is measurable per recist. * primary tumor must have been resected. * four weeks must elapse from prior therapy. * patient has recovered to ctcae \< grade 1 from toxicities related to previous treatment (except non-clinically significant aes). * patient must have adequate organ function. * sexually active fertile patients and their partners must agree to use medically accepted methods of contraception during therapy and 3 months after the last dose of the study drugs. * female patients of childbearing potential must have a negative pregnancy test at screening. * patient must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements. * life expectancy \> 6 months. exclusion criteria: * uncontrolled intercurrent illness or any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results. * current or history of hematologic malignancies. * patient with positive hiv serology at screening. * female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study. * radiation therapy \< 4 weeks prior to screening. * patient has received any other type of investigational agent \< 4 weeks prior to screening. * metastatic brain or meningeal disease. * patient has prothrombin time/international normalization ration (pt/inr) or partial thromboplastin time (ptt) test results \> 1.3 unl. * significant swallowing disorders. * small bowel surgery. * pelvic or abdominal radiation. * pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption. * evidence of concurrent (\< 5 years) second malignancy other than basal cell carcinoma of the skin or cervical carcinoma in situ. * mental disorders. * inability to give written informed consent.

Keywords: tumor cancer metastasis
comparison of cold biopsy forceps vs cold snare for diminutive colorectal polyp removal

Conditions: Colorectal Polyps

Summary: european guidelines recommend the use of cold snare polypectomy (csp) for removal of diminutive colorectal polyps (dcp)(5 mm or less). however, for dcp \< 4 mm cold biopsy forceps (cbf) may be optional. moreover, cbf remains the endoscopist's technique of choice for polyp resection and csp is associated with a failure of specimen retrieval for histology in up to 6.8% of cases. in this study, the investigators aimed to compare the efficacy of csp with cbf for removal of dcp in routine colonoscopy


Eligibility criteria:
inclusion criteria: * routine colonoscopy * patient older than 18 years * at least one polyp measuring ≤ 5 mm exclusion criteria: * inflammatory bowel disease * polyposis syndrome, pregnancy * inability to provide informed consent

Keywords: polypectomy cold biopsy forceps cold snare polypectomy diminutive colorectal polyp
anovaginal distance, interobserver agreement

Conditions: Pelvic Floor Disorders

Summary: interobserver variation in measuring the anovaginal distance (avd) with perineal ultrasound

aims: this study describes perineal ultrasound measurement of the avd in regard to ease of learning and interobserver agreement, in order to establish if the method is reliable to use in further research about objective postpartum description of perineal tears. methods: to educate the examiners, the method was shown and described by an experienced examiner. the examiners then measured the anovaginal distance in one woman repeatedly with until similar results (+/- 5 mm ) were achieved. the woman was in the lithotomy position and a vaginal ultrasound probe was used. the avd in another 40 women was then measured and documented by two examiners, right after the other, who were blinded to the other´s results. the distance was measured between the mucosal margin of the internal anal sphincter and the vaginal probe. interobserver agreement was calculated using kappa-score.

Eligibility criteria:
inclusion criteria: examiners; the gynecologists authoring the study patients: * any women visiting the gynaecological outpatient clinic of linköping university hospital where a vaginal ultrasound examination was performed exclusion criteria: examiners: n/a patients: * inability to understand spoken or written swedish

Keywords: ultrasound anovaginal distance, observer variation
treatment of bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: we are trying to determine if longer duration of therapy with metronidazole or combination therapy of metronidazole plus azithromycin results in better cure rates for bv

bacterial vaginosis (bv) is the most prevalent cause of symptomatic vaginal discharge in the u.s. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (pid), urinary tract infections (uti) and acquisition/transmission of sexually transmitted diseases (stds) including human immunodeficiency virus (hiv). control of bv has been advocated for decreasing the prevalence of these complications. the etiology of bv remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. further, half of all women who meet the clinical diagnostic criteria for bv are asymptomatic and treatment of these women remains controversial. more detailed characterization of the origins, natural history and response to therapy would supply data to guide control efforts. we will approach these problems through a multifaceted interdisciplinary evaluation of women with and without bv. the specific aims {and hypotheses} of this project are: 1. to conduct studies to determine optimal agents and duration of therapy for bv {hypothesis: longer duration of therapy and combination therapy will result in higher cure rates and lower recurrence rates of bv; response to therapy differs between women with asymptomatic bv and symptomatic bv} 2. to examine the role of condoms in the prevention of bv {hypothesis: bv is a sexually transmitted infection, thus recurrence rates of bv will be lower among women with higher condom usage rates} 3. to further explore the role of mobiluncus spp., organisms strongly associated with the syndrome, by utilizing specimens derived from the above studies. {hypothesis: mobiluncus is involved in the pathogenesis of bv at least in a subset of women, and the persistence of this organism is associated with lack of cure and recurrence of bv}

Eligibility criteria:
inclusion criteria: * symptomatic bacterial vaginosis exclusion criteria: * pregnancy * other genital infections

Keywords: bacterial vaginosis treatment
phase i study of hmpl-306 for the treatment of gliomas with idh1 and/or idh2 mutations

Conditions: Gliomas Harboring IDH1 and/or IDH2 Mutations

Summary: this study is a multicenter, randomized controlled phase i clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of hmpl-306 in patients with gliomas harboring idh1 and/or idh2 mutations

hmpl-306 is a dual idh1/2 inhibitor. this is a multicenter, randomized controlled phase i clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of hmpl-306 in patients with gliomas harboring idh1 and/or idh2 mutations. the study consists of 2 parts: part 1 (safety lead-in phase) and part 2 (perioperative phase). part 1 will determine safety and dlt. part 2 will administer the hmpl-306 or no treatment to midh-positive gliomas.

Eligibility criteria:
inclusion criteria: 1. fully informed about the study and voluntarily sign the informed consent form (icf). 2. age ≥ 18 years. 3. safety lead-in phase: patients with gliomas of a documented idh1 and/or idh2 mutation. perioperative study phase: patients with gliomas of definitive or suspected idh1 and/or idh2 mutations scheduled for surgery. 4. all patients must have at least one measurable lesion. 5. karnofsky performance status (kps) score ≥ 80% . 6. in the investigator's judgment, a life expectancy of ≥ 12 weeks. 7. sufficient bone marrow and organ function. exclusion criteria: 1. previous treatment with idh inhibitors. 2. unresolved toxicity from previous antitumor treatments not reverted to ≤ grade 1 (except for alopecia, skin pigmentation changes, and ≤ grade 2 peripheral neuropathy). 3. patients assessed by researchers to have high-risk or unstable conditions. 4. having other malignancies or a history of other malignancies within 5 years prior to screening. 5. history of clinically significant liver disease, including active infection with viral hepatitis, or other active hepatitis, alcoholic liver disease, cirrhosis, etc. 6. patients with hiv infection. 7. pregnancy (positive pregnancy test before dosing) or currently breastfeeding women. 8. presence of diseases or conditions affecting drug absorption. 9. any other conditions, in the investigator's judgment, unsuitable for the study drug, will result in exclusion.

Keywords: gliomas randomized controlled multicenter idh1 mutations idh2 mutations safety run-in mri/mrs examination phase i clinical study pharmacokinetics (pk) pharmacodynamics (pd) efficacy hmpl-306 perioperative study
rhegf incorporated in an absorbable collagen membrane for the management of gingival recession defects

Conditions: Periodontitis

Summary: a sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. at the recession sites rhegf incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

in test site : local anesthesia will be administered and vertical incisions will be given at interdental papillae away from recession defect site and a pouch will be created. a sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. at the recession sites rhegf incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures. in control site: same procedure will be done as the test site but plain collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

Eligibility criteria:
inclusion criteria: * systemically healthy male and female patients of age 20-55 yrs with millers class i or class ii gingival recession are included in the study. exclusion criteria: * patients who are medically compromised and subjects who underwent radiotherapy or chemotherapy and who are smokers are excluded from the study

Keywords: epidermal growth factor gingival recession
hypofractionated versus standard fractionated whole breast irradiation to node-negative breast cancer patients

Conditions: Breast Cancer; Carcinoma in Situ of the Breast

Summary: the purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.

the randomization is between 50 gy/25 fractions, 2.0 gy per fraction, 5 fractions weekly, and 40 gy/15 fractions, 2.67 gy per fraction, 5 fractions weekly. the primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity. the hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.

Eligibility criteria:
inclusion criteria: * operated with breast conserving strategy for: 1. invasive breast cancer, pt1-2, pn0-1mi, m0 or 2. carcinoma in situ of the breast exclusion criteria: * previous radiation of the breast/thorax * breast implants * pregnant/lactating * comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years
diagnosis and characterization of dengue fever in children

Conditions: Dengue Fever

Summary: dengue virus is an arbovirus transmitted by mosquitoes which causes significant morbidity and mortality among children in tropical regions, especially in resource limited countries. the objective of this protocol is to compare the sensitivity and specificity of clinical gestalt and two rapid antigen tests for dengue virus and to compare the gene expression of leukocytes in distinct dengue fever disease phenotypes module-based rna microarray technology.

this is a biology protocol with no treatment regimen associated. blood collection will be drawn from subjects in el salvador to be tested in an effort to improve detection and test sensitivity and specificity of a dengue ns1 ag elisa, dengue ns1 ag strip, and clinical suspicion for the detection of dengue virus infection in children in san salvador, el salvador compared to the gold standard, pcr. this protocol will also seek to identify and compare gene transcription patterns characteristics of each dengue virus disease phenotype in children.

Eligibility criteria:
inclusion criteria part a: * age: greater than or equal to 6 months and less than 13 years * one of the following; history of fever or a history of spontaneous or provoked bleeding inclusion criteria part b: * gender: female * age: greater than or equal to 36 months * tanner stage less than 2 * one of the following criteria: classical dengue fever, dengue hemorrhagic fever or dengue shock syndrome exclusion criteria for both parts: * obvious alternative explanation for the actual illness * cellulitis/abscess * osteomyelitis * varicella * urinary tract infection * known immunocompromising condition
autologous cord blood cell therapy for neonatal encephalopathy

Conditions: Neonatal Encephalopathy; Hypoxic-ischemic Encephalopathy

Summary: this is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.

this is a multicenter pilot study to evaluate the feasibility and safety of intravenous infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). if a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate can receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. the cord blood cells are divided into 3 doses and infused at 12-24, 36-48, and 60-72 hours after the birth. infants will be followed for safety and neurodevelopmental outcome up to 18 months.

Eligibility criteria:
inclusion criteria: infants are eligible if they meet all the following inclusion criteria except 4. 1. ≥36 weeks gestation 2. either a 10-minute apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as ph \<7.0 or base deficit ≥16 mmol/l in a sample of umbilical cord blood or any blood during the first hour after birth 3. moderate to severe encephalopathy (sarnat ii to iii) 4. a moderately or severely abnormal background amplitude-integrated eeg (aeeg) voltage, or seizures identified by aeeg, if monitored 5. up to 24 hours of age 6. autologous umbilical cord blood available to infuse within 3 days after birth 7. a person with parental authority must have consented for the study. exclusion criteria: 1. known major congenital anomalies, such as chromosomal anomalies, heart diseases 2. major intracranial hemorrhage identified by brain ultrasonography or computed tomography 3. severe growth restriction, with birth-weight less than 1800 g 4. severe infectious disease, such as sepsis 5. hyperkalemia 6. outborn infants (infants born at hospitals other than the study sites) 7. volume of collected cord blood \<40 ml 8. infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist

Keywords: neonatal encephalopathy hypoxic-ischemic encephalopathy newborn infants neonates umbilical cord blood cells